Donoso M, Ghaly Evone S
School of Pharmacy, Medical Sciences Campus, University of Puerto Rico, San Juan, Puerto Rico.
Pharm Dev Technol. 2005;10(2):211-7. doi: 10.1081/pdt-54416.
The goals of this study are to user near-infrared reflectance (NIR) spectroscopy to measure the disintegration time of a series of tablets compacted at different compressional forces, calibrate NIR data vs. laboratory equipment data, develop a model equation, validate the model, and test the model's predictive ability. Seven theophylline tablet formulations of the same composition but with different disintegration time values (0.224, 1.141, 2.797, 5.492, 9.397, 16.8, and 30.092 min) were prepared along with five placebo tablet formulations with different disintegration times. Laboratory disintegration time was compared to near-infrared diffuse reflectance data. Linear regression, quadratic, cubic, and partial least square techniques were used to determine the relationship between disintegration time and near-infrared spectra. The results demonstrated that an increase in disintegration time produced an increase in near-infrared absorbance. Series of model equations, which depended on the mathematical technique used for regression, were developed from the calibration of disintegration time using laboratory equipment vs. the near-infrared diffuse reflectance for each formulation. The results of NIR disintegration time were similar to laboratory tests. The near-infrared diffuse reflectance spectroscopy method is an alternative nondestructive method for measurement of disintegration time of tablets.
本研究的目的是使用近红外反射光谱（NIR）来测量一系列在不同压力下压片的片剂的崩解时间，将NIR数据与实验室设备数据进行校准，建立一个模型方程，验证该模型，并测试该模型的预测能力。制备了七种相同组成但崩解时间值不同（0.224、1.141、2.797、5.492、9.397、16.8和30.092分钟）的茶碱片剂配方以及五种崩解时间不同的安慰剂片剂配方。将实验室崩解时间与近红外漫反射数据进行比较。使用线性回归、二次、三次和偏最小二乘技术来确定崩解时间与近红外光谱之间的关系。结果表明，崩解时间的增加会导致近红外吸光度的增加。根据使用实验室设备对崩解时间与每种配方的近红外漫反射进行校准，建立了一系列取决于用于回归的数学技术的模型方程。近红外崩解时间的结果与实验室测试相似。近红外漫反射光谱法是一种用于测量片剂崩解时间的替代性无损方法。
